OAKVILLE, Ontario, June 9, 2026
UCB Canada announced that BIMZELX® (bimekizumab injection) received a positive reimbursement recommendation with conditions from Canada’s Drug Agency (CDA-AMC) for adults with moderate to severe hidradenitis suppurativa (HS) who have shown an inadequate response to conventional systemic therapy. The recommendation was supported by clinical evidence from the Phase 3 BE HEARD I and BE HEARD II trials, along with patient and clinician input highlighting the significant unmet medical need in HS.
Positive Reimbursement Recommendation Expands Access for HS Patients
The CDA-AMC recommendation represents an important step toward broader patient access to BIMZELX for hidradenitis suppurativa across Canada. HS is a chronic inflammatory skin disease characterized by painful nodules, abscesses, and draining lesions, often causing substantial physical discomfort and psychological burden. UCB Canada stated that the recommendation recognizes both the clinical evidence supporting BIMZELX and the need for additional treatment options for patients who continue to experience disease activity despite available therapies.
Phase 3 Clinical Data Supported the Recommendation
The recommendation was based primarily on results from the Phase 3 BE HEARD I and BE HEARD II clinical trials, which evaluated BIMZELX in patients with moderate to severe HS. BIMZELX is a monoclonal antibody targeting both IL-17A and IL-17F, inflammatory cytokines involved in immune-mediated diseases. The therapy is already approved in Canada for several inflammatory conditions, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis, making HS its fifth approved indication in the country.
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UCB Plans Discussions with Public and Private Payers Across Canada
Following the recommendation, UCB Canada will continue discussions with provincial public drug plans and private insurers to support patient access to BIMZELX. The company emphasized its commitment to improving treatment options for people living with severe immune-mediated diseases and advancing care for patients affected by HS. Expanded reimbursement could provide eligible patients with greater access to a biologic therapy designed to reduce inflammation and help address the significant disease burden associated with hidradenitis suppurativa.
Source: UCB Canada press release
